doxorubicin liposome Injectable Solution

Brand(s)
Doxil, LipoDox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-09-22)
Oldest Current Product
1995-11-17
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DOXORUBICIN LIPOSOME
FDAOB
INJECTION\INJECTABLE, LIPOSOMAL\DOXORUBICIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTABLE, LIPOSOMAL\DOXORUBICIN HYDROCHLORIDE
INTRAVENOUS\INJECTION, SUSPENSION, LIPOSOMAL\DOXORUBICIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTABLE, LIPOSOMAL\DOXORUBICIN
INTRAVENOUS\INJECTION, SUSPENSION, LIPOSOMAL\DOXORUBICIN

product(s) by strength(s)

doxorubicin hydrochloride liposome 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350082LipoDoxSun Pharma Global Fze2012-02-09DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTABLE, LIPOSOMAL1d5beebf-77f3-47ca-a9a1-5f64f42fed07
2596760960DoxilNDAJanssen Products, Lp1995-11-17DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTION, SUSPENSION, LIPOSOMALNDA05071821d9c619-7e94-49e2-ac41-31e9ea96554a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1473350049ANDASun Pharma Global Fze2013-02-05DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTABLE, LIPOSOMALANDA203263fbc48fa5-0bfb-4957-b13c-a56bb7a13b56
2473350050ANDASun Pharma Global Fze2013-02-05DOXORUBICIN HYDROCHLORIDEINTRAVENOUSINJECTABLE, LIPOSOMALANDA203263fbc48fa5-0bfb-4957-b13c-a56bb7a13b56

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203263DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)SUN PHARMA GLOBAL FZE2013-02-04ANDA203263_001, ANDA203263_002
2NDA050718DOXIL (LIPOSOMAL)JANSSEN RESEARCH AND DEVELOPMENT LLC1995-11-17NDA050718_001, NDA050718_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA203263_001RXDOXORUBICIN HYDROCHLORIDE (20MG/10ML)INJECTABLE, LIPOSOMALTrueAB2013-02-04DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
2ANDA203263_002RXDOXORUBICIN HYDROCHLORIDE (50MG/25ML)INJECTABLE, LIPOSOMALTrueAB2013-02-04DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
3NDA050718_001RXDOXORUBICIN HYDROCHLORIDE (20MG/10ML)INJECTABLE, LIPOSOMALFalseAB1995-11-17DOXIL (LIPOSOMAL)
4NDA050718_002RXDOXORUBICIN HYDROCHLORIDE (50MG/25ML)INJECTABLE, LIPOSOMALFalseAB2000-06-13DOXIL (LIPOSOMAL)

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11d5beebf-77f3-47ca-a9a1-5f64f42fed07 (view SPL)For the use of an Oncologist or a Cancer Hospital or a Laboratory only.Doxorubicin Hydrochloride Liposome InjectionLIPODOX LIPODOX 50(Pegylated Liposomal)prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2012-05-223473350082, 473350083
221d9c619-7e94-49e2-ac41-31e9ea96554a (view SPL)These highlights do not include all the information needed to use DOXIL safely and effectively. See full prescribing information for DOXIL. DOXIL (doxorubicin hydrochloride liposome injection), for intravenous useInitial U.S. Approval: 1995prescriptionHuman PrescriptionJanssen Products, LpAPI MANUFACTURE, MANUFACTURE2015-09-2215596760960
3fbc48fa5-0bfb-4957-b13c-a56bb7a13b56 (view SPL)These highlights do not include all the information needed to useDOXORUBICIN HYDROCHLORIDE LIPSOME INJECTION safely and effectively. See full prescribing information for DOXORUBICIN HYDROCHLORIDE LIPSOME INJECTION. DOXORUBICIN HYDROCHLORIDE LIPSOME injection, for intravenous use Initial U.S. Approval: 1995prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-09-0310473350049, 473350050

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII